Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Severe side effects may be more likely to occur in infants and children, especially those with spastic paralysis or brain damage. Unusual excitement, nervousness, restlessness, or irritability and unusual warmth, dryness, and flushing of skin are more likely to occur in children, who are usually more sensitive to the effects of belladonna alkaloids. Also, when belladonna alkaloids are given to children during hot weather, a rapid increase in body temperature may occur. In addition, the barbiturate in this medicine could cause some children to become hyperactive.

Geriatric

Confusion or memory loss; constipation; difficult urination; drowsiness; dryness of mouth, nose, throat, or skin; and unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of belladonna alkaloids and barbiturates. Also, eye pain may occur, which may be a sign of glaucoma.

Pregnancy

Information about this belladonna-alkaloids-and-phenobarbital-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ambenonium

Artemether

Atazanavir

Boceprevir

Daclatasvir

Dasabuvir

Delamanid

Isavuconazonium Sulfate

Lurasidone

Maraviroc

Ombitasvir

Paritaprevir

Potassium

Praziquantel

Ranolazine

Rilpivirine

Ritonavir

Telaprevir

Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone

Acenocoumarol

Adinazolam

Alprazolam

Amobarbital

Anisindione

Apixaban

Apremilast

Aprobarbital

Aripiprazole

Axitinib

Bedaquiline

Bortezomib

Bosutinib

Bromazepam

Brotizolam

Buprenorphine

Bupropion

Butabarbital

Butalbital

Cabozantinib

Canagliflozin

Carbinoxamine

Carisoprodol

Ceritinib

Chloral Hydrate

Chlordiazepoxide

Chlorzoxazone

Clarithromycin

Clobazam

Clonazepam

Clorazepate

Clozapine

Cobicistat

Crizotinib

Dabigatran Etexilate

Dabrafenib

Dantrolene

Dasatinib

Delavirdine

Diazepam

Dicumarol

Dolutegravir

Donepezil

Doxorubicin

Doxorubicin Hydrochloride Liposome

Dronedarone

Edoxaban

Eliglustat

Elvitegravir

Enzalutamide

Erlotinib

Eslicarbazepine Acetate

Estazolam

Ethchlorvynol

Etravirine

Everolimus

Exemestane

Fentanyl

Fluconazole

Flunitrazepam

Flurazepam

Halazepam

Hydrocodone

Hydromorphone

Ibrutinib

Idelalisib

Ifosfamide

Imatinib

Irinotecan

Itraconazole

Ivabradine

Ivacaftor

Ixabepilone

Ketazolam

Ketoconazole

Ketorolac

Lapatinib

Ledipasvir

Linagliptin

Lopinavir

Lorazepam

Lormetazepam

Macitentan

Meclizine

Medazepam

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methocarbamol

Methohexital

Methoxyflurane

Midazolam

Mifepristone

Morphine

Morphine Sulfate Liposome

Naloxegol

Netupitant

Nifedipine

Nilotinib

Nimodipine

Nitrazepam

Nordazepam

Olaparib

Orlistat

Oxazepam

Oxymorphone

Palbociclib

Panobinostat

Pazopanib

Pentobarbital

Perampanel

Phenindione

Phenobarbital

Phenprocoumon

Piperaquine

Pomalidomide

Ponatinib

Prazepam

Primidone

Quazepam

Quetiapine

Rivaroxaban

Roflumilast

Romidepsin

Secobarbital

Simeprevir

Sirolimus

Sodium Oxybate

Sofosbuvir

Sorafenib

Sunitinib

Tacrolimus

Tapentadol

Tasimelteon

Temazepam

Temsirolimus

Teniposide

Thiopental

Ticagrelor

Tofacitinib

Tolvaptan

Trabectedin

Triazolam

Ulipristal

Umeclidinium

Vandetanib

Vemurafenib

Vilazodone

Vincristine

Vincristine Sulfate Liposome

Vinflunine

Vorapaxar

Vortioxetine

Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amprenavir

Arbutamine

Betamethasone

Bexarotene

Cannabis

Carbamazepine

Chlorpromazine

Cortisone

Desogestrel

Dexamethasone

Dienogest

Digitoxin

Drospirenone

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethosuximide

Ethynodiol Diacetate

Etonogestrel

Felodipine

Ginkgo

Granisetron

Griseofulvin

Lamotrigine

Leucovorin

Levomethadyl

Levonorgestrel

Medroxyprogesterone Acetate

Mestranol

Methylprednisolone

Metoprolol

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Ospemifene

Oxcarbazepine

Prednisone

Quinidine

Quinine

Risperidone

Rufinamide

Telithromycin

Theophylline

Thioridazine

Tiagabine

Tipranavir

Topiramate

Valproic Acid

Verapamil

Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or

Dry mouth or

Emphysema (type of lung disease) or

Enlarged prostate or

Glaucoma or

Heart disease or

Hyperactivity (in children) or

Intestinal blockage or

Ulcerative colitis or

Urinary tract blockage or difficult urination—Use with caution. May make these conditions worse.

Down's syndrome—Use with caution. May make the side effects worse.

Kidney disease or

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.